What is intranasal foralumab, and why is Tiziana Life Sciences (NASDAQ: TLSA) studying it in neurological diseases?
What is intranasal foralumab? The answer begins with a growing area of medical research: the connection between the immune system and inflammation inside the brain. Keep reading to find out how impressive intranasal foralumab is.
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Foralumab is an investigational monoclonal antibody targeting CD3, a protein involved in T-cell signaling. Tiziana is researching whether administering this antibody through the nasal passage can influence immune regulation and neuroinflammatory activity.
Unlike medicines designed to target one specific disease-associated protein, this research examines the immune system’s regulatory pathways.
The approach has attracted scientific interest in multiple sclerosis, Alzheimer’s disease, and other neurological conditions. But the distinction is important: intranasal foralumab is not an approved treatment, and its clinical effectiveness remains under investigation.
Understanding the science helps explain what researchers are measuring, what early studies have observed, and which questions remain unanswered.
What Is Intranasal Foralumab? Tiziana Life Sciences (TLSA)
1. What Is Intranasal Foralumab?
Intranasal foralumab is an experimental biologic medicine developed by Tiziana Life Sciences.
Its active ingredient is a fully human anti-CD3 monoclonal antibody.
Monoclonal antibodies are laboratory-produced proteins designed to interact with specific biological targets. CD3 forms part of the signaling machinery associated with T cells, a type of white blood cell involved in immune responses.
Foralumab’s development program explores whether targeting this pathway through nasal administration can produce immune-regulatory effects.
The treatment is being investigated as a biologic drug, not as an ordinary over-the-counter nasal spray.
Its safety, dosage, and biological effects are studied within controlled clinical research programs.
2. How Does Intranasal Foralumab Work? Understanding Regulatory T Cells
One of the central ideas behind foralumab research involves regulatory T cells, commonly called Tregs.
The immune system must accomplish two competing tasks.
It needs to respond to infections and other threats, but it must also prevent unnecessary or excessive immune activity.
Regulatory T cells help maintain that balance.
Scientists are investigating whether intranasal anti-CD3 administration can influence these regulatory pathways and associated inflammatory signaling.
The proposed process involves several biological steps:
- Nasal administration exposes immune tissues to the antibody.
- Anti-CD3 activity influences T-cell regulatory signaling.
- Researchers examine changes in immune-cell populations and inflammatory markers.
- Brain imaging and clinical assessments evaluate whether measurable effects occur.
These steps describe the scientific rationale being investigated, not a fully established treatment mechanism in humans.
Importantly, a nasal route of administration does not automatically mean the antibody travels directly into the brain.
3. Why Is Neuroinflammation Important in Multiple Sclerosis and Alzheimer’s Disease?
Neuroinflammation refers to inflammatory processes involving the brain or other parts of the nervous system.
These processes can be protective during injury or infection. However, persistent or poorly regulated inflammatory activity is also being studied in neurological disease.
A central part of this research concerns microglia.
Microglia are immune-related cells within the central nervous system. They participate in surveillance, tissue maintenance, and responses to injury.
Researchers are investigating how sustained microglial activation relates to neurological damage and disease progression.
In multiple sclerosis, inflammation can contribute to damage affecting myelin and nerve fibers.
In Alzheimer’s disease, investigators study inflammatory activity alongside amyloid and tau pathology.
These conditions have different causes and clinical characteristics. The presence of neuroinflammation in both does not mean the same treatment will work for both.
For Tiziana, the research question is whether intranasal foralumab can produce measurable changes in relevant immune pathways.
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4. How Do Scientists Measure Brain Inflammation? The Role of PET Imaging
An interesting aspect of intranasal foralumab research is the use of advanced brain imaging.
Several studies employ TSPO-PET imaging, a technique used to assess biological signals associated with neuroinflammatory activity.
PET stands for positron emission tomography.
TSPO refers to the translocator protein, a biological marker whose expression can increase in activated immune-related cells.
Researchers administer an imaging tracer and measure its distribution to evaluate changes in TSPO-related signals.
This creates a way to study biological activity that cannot be measured simply by asking patients how they feel.
However, TSPO is not exclusive to microglia, and a change in an imaging signal is not automatically proof of improved neurological function.
That is why clinical trials also include physical assessments, cognitive testing, symptom measurements, and safety monitoring.
A biological finding becomes more informative when it can be examined alongside meaningful clinical outcomes.
5. What Has Intranasal Foralumab Research Shown in Humans?
In January 2026, researchers published a study in Neurology: Neuroimmunology & Neuroinflammation involving 10 patients with non-active secondary progressive multiple sclerosis.
Participants received nasal foralumab for at least six months in an open-label study.
Researchers reported several observations:
- All 10 participants showed stabilization on the Expanded Disability Status Scale during the observed period.
- Three of four patients treated continuously for 12 months demonstrated improvement on that disability measure.
- Six of 10 participants showed improvement in fatigue scores.
- TSPO-PET imaging detected reductions in measured inflammatory signals.
- No treatment-related serious adverse events were reported in the study.
These findings were published in a peer-reviewed medical journal.
However, the study was small and did not include a randomized placebo-control group.
Consequently, the findings cannot establish that foralumab caused the observed clinical changes.
The publication classified its evidence as Class IV, reflecting important limitations in drawing conclusions about treatment effectiveness.
6. How Is Tiziana Life Sciences Testing Foralumab More Rigorously?
To address questions that smaller studies cannot resolve, Tiziana has been conducting randomized clinical research.
Its Phase 2a INFORM-MS trial enrolled 48 patients with non-active secondary progressive multiple sclerosis.
The trial compares two doses of intranasal foralumab with placebo over a 12-week treatment period.
Measurements include PET imaging of neuroinflammatory activity, disability assessments, fatigue scores, safety, and tolerability.
In September 2026, the company announced completion of the final participant’s scheduled trial visit.
Completion of visits is a study milestone, but conclusions about effectiveness require analysis of the trial results.
Separately, Tiziana has been evaluating foralumab in a Phase 2 Alzheimer’s disease study, including investigation alongside approved anti-amyloid treatments.
These studies examine different diseases and endpoints. Results from one cannot be assumed to demonstrate effectiveness in another.
7. What Does This Research Mean for Tiziana Life Sciences (TLSA)?
For readers examining Tiziana Life Sciences stock, the research record provides information about its scientific strategy.
The company is investigating whether one immune-regulatory approach can be studied across multiple neurological indications.
But scientific rationale, early biological observations, and completed patient visits are not equivalent to regulatory approval or commercial success.
Tiziana’s financial disclosures also deserve attention.
In its October 16, 2026 interim report, the company reported a $12.4 million comprehensive loss for the six months ended June 30.
It disclosed approximately $3.2 million in cash at June 30 and $3.9 million as of October 16.
The filing identified material uncertainty concerning its ability to continue operating without obtaining additional financing.
Those factors highlight the development and funding risks associated with clinical-stage biotechnology businesses.
Review Tiziana’s SEC-filed interim financial report.
Frequently Asked Questions About Intranasal Foralumab
Is intranasal foralumab FDA-approved?
No. Intranasal foralumab remains an investigational medicine. Its safety and efficacy for routine clinical treatment have not been established.
Is foralumab the same as an Alzheimer’s anti-amyloid drug?
No. Foralumab targets the CD3-associated immune pathway. Anti-amyloid medicines such as lecanemab and donanemab have different biological targets.
Why administer foralumab through the nose?
Researchers are studying nasal administration as a method of influencing immune regulation. The possible advantages and limitations require evaluation through clinical trials.
What is the connection between foralumab and regulatory T cells?
Regulatory T cells help maintain immune balance. Research into nasal anti-CD3 antibodies examines whether changes in these immune pathways correspond with measurable biological or clinical effects.
The Bottom Line: What Is Intranasal Foralumab?
Intranasal foralumab represents an investigational approach to neurological research that examines immune regulation rather than focusing exclusively on disease-specific proteins.
Tiziana Life Sciences (NASDAQ: TLSA) is studying the antibody through a combination of clinical assessments, immune-cell measurements, and advanced neuroinflammation imaging.
Peer-reviewed early research provides observations about biological activity, while randomized trials are designed to answer more rigorous questions about safety and clinical effects.
For readers following neurological drug development, the central story is how researchers are testing the connection between immune regulation and the nervous system.
For additional company-specific context, read our earlier report on five clinical milestones in Tiziana Life Sciences’ 2026 foralumab program.
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